510(k) K981838 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
| Applicant | Unotech Diagnostics, Inc., San Leandro CA, US |
| Decision | Substantially Equivalent, Jun 25, 1998 |
| Received | May 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981838
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.